MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 NH TEST KIT

Catalog Number 21346

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer from (b)(6) reported to biomérieux a misidentification of a campylobacter jejuni ssp.Jejuni quality control sample (atcc 33560), as campylobacter coli in association with the vitek® 2 nh test kit.The customer confirmed that the strain was c.Jejuni ssp.Jejuni via maldi-tof method and offline hippurate test (positive reaction is observed; c.Jejuni ssp.Jejuni exhibits positive hippurate, while c.Coli exhibits negative hippurate).The isolate was tested with the vitek® 2 nh three times, with cultures from different media [once from cba (validated) and twice from campy agar (not validated)], and all results were given c.Coli with 99% probability.There was no patient involvement as the event pertained to a quality control sample.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

This report was initially submitted in response to notification from a customer in (b)(6) regarding a misidentification of campylobacter jejuni ssp.Jejuni quality control sample (atcc® 33560¿), as campylobacter coli in association with the vitek® 2 nh test kit.Internal biomérieux investigation was conducted.However, the strain and raw data were not available for submittal by the customer.The customer reported setting up the strain on cba and campy agar (not a validated media) after incubating for 24 hours in a micro-aerophilic environment at 42 degrees c.They received a misidentification from both media types.One lab report was submitted showing an excellent identification of campylobacter coli with four (4) atypical reactions (+:phea and -:odc, pyra, ops) according to the nh knowledge base for an identification of campylobacter jejuni ssp jejuni.Campylobacter jejuni ssp jejuni atcc 33560 was tested three (3) times during development of the nh id card and gave a low-discrimination identification each time between campylobacter jejuni ssp jejuni and campylobacter coli.As campylobacter jejuni ssp jejuni was included in the low-discrimination call, the result is acceptable.Note: this strain is not included as a qc strain in the nh id instructions for use (ifu).An increased number of atypical reactions can indicate contamination, mixed culture, compromised viability of the strain, use of non-recommended media or other user set up errors or an atypical strain.However without the strain or raw data it's not possible to further evaluate the cause of the misidentification.Nh lot #2450438123 and 2450389203 met final qc release criteria.The lots passed qc performance testing.The investigation concluded there is no investigational evidence to suggest the vitek 2 nh id card is performing outside of specifications.

• Brand Name: VITEK® 2 NH TEST KIT
• Type of Device: VITEK® 2 NH TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer Contact: jeff scanlan ; 595 anglum road; hazelwood, MO 63042 ; 3147318694
• MDR Report Key: 7100009
• MDR Text Key: 95743085
• Report Number: 1950204-2017-00437
• Device Sequence Number: 1
• Product Code: JST
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: C1 EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/20/2018
• Device Catalogue Number: 21346
• Device Lot Number: 2450389203
• Other Device ID Number: 03573026144357
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/14/2017
• Initial Date FDA Received: 12/08/2017
• Supplement Dates Manufacturer Received: 04/17/2018
• Supplement Dates FDA Received: 05/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1